Contact information
Type
Scientific
Primary contact
Dr Melba Gomes
ORCID ID
Contact details
20
Avenue Appia
Geneva -27
CH 1211
Switzerland
gomesm@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
A30765
Study information
Scientific title
Acronym
Study hypothesis
Pharmacokinetic studies have shown that pentamidine has a large volume of distribution and elimination occurs over a long period. The objective of the study is to assess the efficacy of 3 days Intramuscular (IM) pentamidine treatment compared to the standard 7 days IM pentamidine treatment regimen.
Ethics approval
Ethics approval received from:
1. World Health Organization (WHO)/Ethics Review Committee (ERC) on the 4th December 2003
2. Instituto de Combate e Control o Das Triponosommiases (ICCT) (Angola) on the 18th October 2004
3. Wandsworth Local Research Ethics Committee (UK) on the 3rd December 2003
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Human African Trypanosomiasis (HAT)
Intervention
This will be an open, randomised comparison of two pentamidine treatment regimens, given over three days or seven days with a non-inferiority trial design.
Intervention type
Drug
Phase
Not Specified
Drug names
Pentamidine
Primary outcome measures
Proportion of cases with favourable progress at 6 months, based on clinical state and laboratory status.
Secondary outcome measures
1. Proportion of cases with favourable progress at discharge, 3 and 12 months based on clinical state and laboratory status
2. Cure rate at 18 months, based on based on clinical state and laboratory status
3. Frequency and severity of adverse events
Overall trial start date
20/12/2004
Overall trial end date
20/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged more than or equal to 14 years and less than 60 years
2. Parasite positive (on examination of lymph juice, by Capillary Tube Centrifugation [CTC] or miniature Anion-Exchange Centrifugation [mAEC] on whole blood)
3. Alternative diagnoses excluded clinically and by appropriate laboratory investigations
4. Capable of and giving informed consent to the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
The total target was 440 patients, but only 18 were recruited in this site.
Participant exclusion criteria
1. Stage II Human African Trypanosomiasis (HAT): defined as parasites in cerebrospinal fluid (CSF), or having more than or equal to 6 cells/mm^3 in CSF; or more than 100 red cells/mm^3 ("bloody tap")
2. Pregnant
3. Previous HAT
4. Known allergy or reactions to pentamidine
5. Diabetes mellitus
6. Difficulty to comply with follow-up (patients of no fixed abode and refugees, for example)
Recruitment start date
20/12/2004
Recruitment end date
20/12/2006
Locations
Countries of recruitment
Angola
Trial participating centre
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
Sponsor information
Organisation
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Sponsor details
20
Avenue Appia
Geneva -27
CH 1211
Switzerland
Sponsor type
Other
Website
Funders
Funder type
Research organisation
Funder name
United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary